Do Safety Warnings Change Prescribing among the US Dialysis Population?

安全警告会改变美国透析人群的处方吗？

• 批准号: 8267550
• 负责人: Mae Thamer
• 金额: $ 5.06万
• 依托单位: MEDICAL TECHNOLOGY AND PRACTICE PATTERNS
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-01 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8267550
• 关键词: Do; Safety; Warnings; Change; Prescribing

Do Safety Warnings Change Prescribing among the US Dialysis Population? ABSTRACT Objectives On March 9, 2007, FDA issued a public health advisory and Black Box warning outlining new safety information, including revised product labeling about erythropoiesis- stimulating agents (ESAs), widely-used drugs for the treatment of anemia associated with renal disease. The goal of this proposal is to determine if these new recommendations resulted in a change in physician prescribing among all US dialysis patients covered by the Medicare End-Stage Disease (ESRD) program. Methods Computerized United States Renal Disease System (USRDS) data from March 2006 through March 2009 are proposed to evaluate prescribing patterns in the year before and two years after the FDA Public Health Advisory. An interrupted time series model, based on all outpatient dialysis encounters indicating use of ESAs will be used to assess the impact of the FDA Black Box Warnings in influencing physician prescribing. Results We will show trends in prescribing of ESAs for anemia associated with renal failure (commonly found among nearly all dialysis patients) before and after the FDA warnings. We will assess whether changes in prescribing can be attributed to the FDA Public Health Advisory. Results will be stratified by patient demographics (age, race, gender), responsiveness to therapy (achieved hemoglobin >10 g/dL), cause of ESRD (diabetes, hypertension, etc.), vintage (length of time on dialysis), and facility characteristics (chain status, size of facility and profit status). Conclusions/Implications We will show whether two years after a highly publicized FDS Public Health Advisory (a Black Box Warning that went out to all practicing nephrologists) indicating the safety risks associated with ESA therapy and recommendations to use 'the lowest dose possible to avoid blood transfusions' resulted in a decline in the previously high ESA doses observed among dialysis patients. Using 'real world' prescription data among a census of Medicare ESRD patients on dialysis, we will investigate whether the FDA recommendations from the March 2007 advisory meeting were coincident with a change in physician prescribing patterns. We will show whether - without accompanying changes in the reimbursement structure, i.e., higher ESA doses continued to be profitable during our study period - physicians changed their ESA prescribing habits as a result of the FDA warnings. This study presents a unique opportunity to examine the dissemination of grave Black Box warnings and the willingness of physicians to modify prescribing habits in treating a vulnerable population of dialysis patients.

安全警告会改变美国透析人群中的处方吗？ 抽象的 目标 2007年3月9日，FDA发布了公共卫生咨询和黑匣子警告概述 新的安全信息，包括有关红细胞生成的产品标签 - 刺激剂（ESA），广泛使用的药物用于治疗贫血 肾脏疾病。该提议的目的是确定这些新建议是否 在所有美国透析患者中​​，医师开处方的变化 Medicare终阶段疾病（ESRD）计划。 方法 2006年3月的计算机化美国肾脏疾病系统（USRDS）数据 提议到2009年3月，旨在评估前一年的处方模式 FDA公共卫生咨询两年后。一个中断的时间序列模型， 基于所有门诊透析遭遇，表明使用ESA用于评估 FDA黑匣子警告在影响医师处方的影响。 结果 我们将显示出与肾衰竭相关的贫血的ESA处方的趋势 （通常在几乎所有透析患者中​​发现）在FDA警告之前和之后。 我们将评估是否可以将处方更改归因于FDA公共卫生 咨询。结果将由患者人口统计（年龄，种族，性别）进行分层 对治疗的反应（达到的血红蛋白> 10 g/dL），ESRD（糖尿病，， 高血压等），复古（透析时间长度）和设施特征（链 状态，设施规模和利润状态）。 结论/含义 我们将展示是否在高度宣传的FDS公共卫生咨询后两年（a 黑匣子警告向所有执业肾病学家发出的警告）表明安全性 与ESA治疗相关的风险和建议使用最低剂量的建议 为了避免输血，导致以前高ESA剂量下降 在透析患者中​​观察到。在人口普查中使用“现实世界”处方数据 Medicare ESRD患者透析，我们将调查FDA是否是否 2007年3月咨询会议的建议与更改相吻合 在医师开处方模式中。我们将展示是否 - 不伴随 报销结构的变化，即更高的ESA剂量继续是有利可图的 在我们的学习期间 - 医生因 FDA警告。这项研究提供了一个独特的机会来检查 传播严重的黑匣子警告和医生修改的意愿 处方习惯在治疗弱势透析患者人群中。